Protective Wear for Transplanted Kidney

ABSTRACT

A protective device and pad are disclosed. The protective device includes a garment or belt configured for securing a pad that has a lateral side shorter than a medial side over a portion of an abdomen/pelvis of a subject.

BACKGROUND

The present invention relates to protective wear and, more particularly, to a protective device that includes an asymmetric pad designed for effectively protecting an implanted kidney during exercise.

Chronic kidney disease is a major health concern afflicting more than eight million Americans. Decline of kidney function below a certain level leads to end-stage renal disease and requires dialysis or transplantation to sustain life.

Kidney transplantation was the first of the organ transplant procedures to develop due to availability of live donors. In most cases, the existing kidney of the recipient is not removed since it has been shown to increase the rates of surgical morbidity. The transplanted kidney is usually placed in the pelvic cavity (a part of the abdominopelvic cavity) with the renal artery of the new kidney connected to the external iliac artery and the renal vein connected to the external iliac vein. The ureter of the transplanted kidney is anastomosed with the recipient bladder.

Since transplanted kidneys are transplanted to an anatomically unnatural site, they are exposed to trauma that can lead to kidney failure.

The most common trauma is external and can result from an object such as a ball, sports equipment, another person or even a stationary object (wall, ground) slamming against the kidney transplant area.

Since trauma can result in kidney failure, doctors often recommend use of protective wear for kidney recipients that participate in contact or extreme sports.

Several protective wear devices are available on the market including the WSI Wikmax kidney protection shirt, the Zoobang protector and the TKO kidney protector.

While these devices are effective in protecting the transplanted kidney from blunt trauma when properly positioned over the implant site, they can shift during movement resulting in less than optimal coverage of the transplant site.

There is thus a need for, and it would be highly advantageous to have, a protective device that can effectively protect an implanted kidney from trauma during exercise.

SUMMARY

According to one aspect of the present invention there is provided a protective device comprising a pad attached to a garment or belt configured for securing the pad over a portion of an abdomen/pelvis of a subject, the pad having medial and lateral sides, wherein the lateral side is shorter than the medial side.

According to embodiments of the present invention the pad is an irregular pentagon having an area of 150-200 cm².

According to embodiments of the present invention a distal side of the pad is shorter than a proximal side thereof.

According to embodiments of the present invention the medial side of the pad is substantially perpendicular to a waist line of the subject when the device is worn.

According to embodiments of the present invention the pad includes at least two layers, a first layer 3-6 mm thick and having a density of 10-15 lbs/ft³ and a second layer 5-8 mm thick and having a density of 20-30 lbs/ft³.

According to embodiments of the present invention the pad is segmented through at least one layer of the at least two layers.

According to embodiments of the present invention the pad includes at least 4 segmented regions capable of angling with respect to each other.

According to embodiments of the present invention the belt includes a pouch for carrying the pad.

According to embodiments of the present invention the belt includes a dorsal closure mechanism.

According to embodiments of the present invention the dorsal closure mechanism is adjustable without altering a position of the pad over the portion of the abdomen/pelvis.

According to another aspect of the present invention there is provided a method of protecting an implanted kidney of a subject comprising securing a pad over a portion of the subjects abdomen/pelvis external to a site of implantation of the kidney, the pad having medial and lateral sides, wherein the lateral side is shorter than the medial side.

According to embodiments of the present invention securing is effected via a belt.

According to embodiments of the present invention the belt includes a pouch for carrying the pad.

According to embodiments of the present invention the belt includes a dorsal closure mechanism.

According to embodiments of the present invention the securing includes adjusting the dorsal closure mechanism without altering a position of the pad over the portion of the abdomen/pelvis.

Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention, suitable methods and materials are described below. In case of conflict, the patent specification, including definitions, will control. In addition, the materials, methods, and examples are illustrative only and not intended to be limiting.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention is herein described, by way of example only, with reference to the accompanying drawings. With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way of example and for purposes of illustrative discussion of the preferred embodiments of the present invention only, and are presented in the cause of providing what is believed to be the most useful and readily understood description of the principles and conceptual aspects of the invention. In this regard, no attempt is made to show structural details of the invention in more detail than is necessary for a fundamental understanding of the invention, the description taken with the drawings making apparent to those skilled in the art how the several forms of the invention may be embodied in practice.

In the drawings:

FIGS. 1A-C illustrate top (FIG. 1A), side (FIG. 1B) and perspective (FIG. 1C) views of one embodiment of the present protective pad.

FIGS. 1D-E illustrate the front (FIG. 1D) and back (FIG. 1E) sides of one embodiment of a belt that can be used in the protective device of the present invention.

FIGS. 2A-B illustrate a protective wear device that includes the present pad (FIG. 2A) and a standard rectangular pad (FIG. 2B).

FIG. 3 illustrates a standard protective wear device worn on a subject.

FIG. 4 illustrates the shift following light exercise of the protective wear device of FIG. 2B.

FIG. 5 illustrates one embodiment of the present protective wear device worn on a subject.

FIG. 6 illustrates the shift following light exercise of the present protective wear device of FIG. 2A.

DETAILED DESCRIPTION

The present invention is of a protective pad and protective wear device which can be used to protect a transplanted kidney. Specifically, the present invention can be used to protect a transplanted kidney from impact trauma during exercise.

The principles and operation of the present invention may be better understood with reference to the drawings and accompanying descriptions.

Before explaining at least one embodiment of the invention in detail, it is to be understood that the invention is not limited in its application to the details set forth in the following description or exemplified by the Examples. The invention is capable of other embodiments or of being practiced or carried out in various ways. Also, it is to be understood that the phraseology and terminology employed herein is for the purpose of description and should not be regarded as limiting.

Protective wear devices that can be used to protect a transplanted kidney are known in the art. Such devices provide ample protection from blunt force trauma when correctly positioned. However, any shift of such device during movement can expose the transplant area to trauma and can reduce their protective effect.

While reducing the present invention to practice, the present inventors experimented with several pad and belt designs in order to address the limitations of prior art protective wear.

Development of the present pad and protective wear design followed several guidelines including, but not limited to:

(i) Protective pad should remain stationary and cover the implant region during extreme body movement;

(ii) Protective pad should be rigid enough to absorb 50% (or more) of the blunt force of and yet be flexible enough to move with the skin and comfortable to wear;

(iii) Protective pad should be lightweight (the entire belt should not weigh more than 250 grams) and thin with minimal appearance when worn under clothing;

(iv) The belt should be easily mounted and secured by the user in less than 30 seconds; and

(v) The belt should be comfortable throughout various postures (seating, standing, lying on the back, lying on the stomach, squatting, etc.).

In order to provide the above requirements, the present inventors designed a protective device that includes a pad that is asymmetric (and preferably 5 sided) and has a lateral side that is shorter than a medial side. As used herein, “lateral” defines an outer side (away from midline of body) of the pad when positioned over the abdominal/pelvic region overlying the implant site while “medial” refers to the inner side (toward the midline of the body).

Thus, when worn, the shorter side of the pad is near the hip bone while the longer side is near the belly button.

In addition to its asymmetry, the protective pad of the present invention includes several layers (e.g., 2, 3, 4 or 5) of a protective material of varying thickness and density.

Such construction allows use of a less dense (softer) material in the layer facing the skin (inner layer) and a denser (harder) material facing outwardly (outer layer). The outer layer serves to stop impact while the inner layer serves to dissipate such impact. The inner layer can be glued to the outer layer or alternatively over-molded thereupon.

In order to enable the pad to flex with the skin and yet provide a substantially dense and rigid outer layer that can protect against a large impact force, the outer layer can be segmented into 2-8 regions of various geometric shapes (e.g. square, rectangular, trapezoid). Such segmentation can be effected by cutting channels or grooves through the outer layer following construction of the pad or by over-molding the segmented outer layer over the inner layer. In any case, these grooves serve as an elastic hinge that enables independent flexion of outer layer regions.

The pad can be shaped as an irregular pentagon with an area of 150-200 cm² and a total thickness of 6-14 mm. When viewed in position, the pad sides can have a length of 130-220 mm (top), 50-110 mm (bottom), 70-130 mm (medial), 30-70 mm (lateral) and 100-180 mm (side connecting bottom to lateral).

The inner layer can be fabricated from a material such as non-Newtonian polymer by XRD or D3O or having a thickness of 3-6 mm and a density of 10-15 lbs/ft³. The outer layer can be fabricated from a material such as XRD or D3O having a thickness of 5-8 mm and a density of 20-30 lbs/ft³.

The pad of the present invention can be carried via any garment or belt. For example, the pad can be incorporated into a pocket formed in a shirt (e.g. cycling jersey) or a pouch of a belt.

A belt is advantageous in that it can secure the pad firmly over the abdominal-pelvic area overlying the implant site.

One belt configuration can be worn under or above a shirt, is thin, discrete, with minimal surface coverage and can be tightened or loosened according to body size and comfort of the user.

One embodiment of the present pad, referred to herein as pad 10, is shown in FIGS. 1A-C.

Pad 10 includes two layers, an inner layer 12 and an outer layer 14 that are glued together or co-molded. Inner layer 12 has a density of (10-15 lbs/ft³) and is softer than outer layer 14 (density of 20-30 lbs/ft³). Inner layer 12 covers a slightly larger area (170 cm²) than outer layer 14 (150 cm) and provides a soft interface against the skin. Outer layer 14 provide impact protection and is segmented via grooves 16 into 5-7 regions 18 each having a roughly trapezoidal shape and an area of 1500-3900 mm².

Grooves 16 can extend the entire thickness of outer layer 14 or a portion; grooves 16 can be 3-4 mm in width.

As is mentioned hereinabove, pad 10 can be incorporated into a garment/belt to form a protective device that can be worn by the subject.

A belt 20 suitable for use with pad 10 is shown in FIGS. 1D-E. Belt 20 includes Neoprene fabric 22 and DryFit fabric 24, a zipper-type closing mechanism 26, an adjustment mechanism 28 that includes stiff durable fabrics, two D-rings 30, and straps 32 that can be looped through rings 30 and secured thereto to enable the subject to adjust and secure belt 20 and attached pad 10 over the protected region of the body of the subject.

To use the present protective the device, a user simply wraps the belt over the lower abdomen with the pad aligned over the protected region (the area between the navel and the pelvis bone) and zips the zipper.

The user then threads the straps through the D-rings and adjusts for securement and comfort by pulling and securing the straps.

As used herein the term “about” refers to ±10%.

Additional objects, advantages, and novel features of the present invention will become apparent to one ordinarily skilled in the art upon examination of the following examples, which are not intended to be limiting.

EXAMPLES

Reference is now made to the following example, which together with the above descriptions, illustrate the invention in a non-limiting fashion.

Testing Pad Displacement During Movement

In active individuals, especially individuals that participate in a sport that can potentially involve impact trauma (e.g. surfing, soccer football, cycling etc.) a protective pad must maintain its position over a pelvic region overlying an implant site throughout exercise. Any movement during exercise that displaces the pad from the site of desired protection exposes the implant to impact and potential trauma that can lead to kidney failure.

The present protective wear (FIG. 2A) and a standard protective pad configuration (FIG. 2B) were tested for their ability to maintain position during light exercise.

A subject wearing either the standard protective wear (FIG. 3) or the present protective wear (FIG. 5) was instructed to sit and stand up 10 times following which a shift in the pad position was marked on the body of the subject for both the standard pad (FIG. 4) and the present pad (FIG. 6).

As is clearly shown in FIGS. 4 and 6, the shift with the present pad was a fraction of the shift recorded for the standard pad. The measured shift for the standard pad (longitudinal displacement) was 44±1 mm whereas the shift for the present pad was 6±1 mm. Thus, the present pad can effectively cover the implant site during exercise and would be markedly more effective than a standard pad in protecting an implanted kidney from impact trauma.

It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable subcombination.

Although the invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications and variations that fall within the spirit and broad scope of the appended claims. All publications, patents and patent applications mentioned in this specification are herein incorporated in their entirety by reference into the specification, to the same extent as if each individual publication, patent or patent application was specifically and individually indicated to be incorporated herein by reference. In addition, citation or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the present invention. 

What is claimed is:
 1. A protective device comprising a pad attached to a garment or belt configured for securing said pad over a portion of an abdomen/pelvis of a subject, said pad having medial and lateral sides, wherein said lateral side is shorter than said medial side.
 2. The device of claim 1, wherein said pad is an irregular pentagon having an area of 150-200 cm².
 3. The device of claim 1, wherein a distal side of said pad is shorter than a proximal side thereof.
 4. The device of claim 1, wherein said medial side of said pad is substantially perpendicular to a waist line of said subject when the device is worn.
 5. The device of claim 1, wherein said pad includes at least two layers, a first layer 3-6 mm thick and having a density of 10-15 lbs/ft³ and a second layer 5-8 mm thick and having a density of 20-30 lbs/ft³.
 6. The device of claim 5, wherein said pad is segmented through at least one layer of said at least two layers.
 7. The device of claim 6, wherein said pad includes at least 4 segmented regions capable of angling with respect to each other.
 8. The device of claim 1 wherein said belt includes a pouch for carrying said pad.
 9. The device of claim 1, wherein said belt includes a dorsal closure mechanism.
 10. The device of claim 9, wherein said dorsal closure mechanism is adjustable without altering a position of said pad over said portion of said abdomen/pelvis.
 11. A method of protecting an implanted kidney of a subject comprising securing a pad over a portion of the subjects abdomen/pelvis external to a site of implantation of the kidney, said pad having medial and lateral sides, wherein said lateral side is shorter than said medial side.
 12. The method of claim 11, wherein securing is effected via a belt.
 13. The method of claim 12, wherein said belt includes a pouch for carrying said pad.
 14. The method of claim 12, wherein said belt includes a dorsal closure mechanism.
 15. The method of claim 14, wherein said securing includes adjusting said dorsal closure mechanism without altering a position of said pad over said portion of said abdomen/pelvis. 